Non-small Cell Lung CancerPhase 2NCT02734524
A Clinical Research of NK Cell Infusion Combined With Chemotherapy in the Treatment of Non-small Cell Lung Cancer
A Phase 2 study testing NK cells, Taxol and Carboplatin in people with Non-small Cell Lung Cancer, run by Southwest Hospital, China at 1 site in China.
Trial summary
The main purpose of this study is to explore if the combination of autologous NK cell infusion and chemotherapy can increase the therapeutic efficiency in the treatment of non-small cell lung cancer compared with chemotherapy alone. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- NK cells, Taxol and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Mar 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-small cell lung cancer must be diagnosed by pathology and staged as ⅢB or Ⅳ with 2009-UICC TNM staging system and operation is excluded due to medical reasons or patient's will.
- According to Response Evaluation Criteria in Solid Tumors(RECIST), at least one measurable or evaluable nidus can be detected by chest CT.
- ECOG score 0-1.
- Gender is not limited, age from 18 years to 75 years.
- Patients are expected to survive for more than 3 months by their physicians at the time of enrollment.
- Mental state is evaluated as normal.
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- Adequate cardiac function(LVEF≥40%, tested within one month) without heart diseases.
- Hepatic and renal function were normal, biochemical criterion must meet the requests below: white blood cell count≥2.5×10^9/L，platelet count≥100×10^9/L，hemoglobin≥90g/L, serum bilirubin≤2 upper limit of normal(ULN), AST and ALT≤2 ULN(AST, ALT≤5ULN under hepatic metastases), Bun≤2 ULN, serum creatinine≤2 ULN.
- No other serious illnesses(e.g.,autoimmune disease, immunodeficiency, ect.).
- Ability to give informed consent.
- No other malignancies diagnosed.
- Patients volunteer to participate in the research.
Who cannot join
- Subjects meeting any of the following criteria are not eligible for participation in the study:
- Frequent infection history and recent infection is uncontrolled.
- Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
- Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. For additional details regarding use of steroid and immunosuppressant medications.
- Pregnancy and nursing females.
- HIV infection.
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- Active hepatitis B or active hepatitis C.
- Participation in a prior investigational study within 4 weeks prior to enrollment or longer if required by local regulation. Participation in non-therapeutic research studies is allowed.
- Class III/IV cardiovascular disability according to the New York Heart Association Classification.
- Patients with a known history or prior diagnosis of other serious immunologic, malignant or inflammatory disease.
- Other situations we think not eligible for participation in the research.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southwest Hospital of Third Millitary Medical University
Chongqing, Chongqing Municipality, 400000
Cheng Qian, PhD, 008615086883400, cqian3184@163.com
Zhi Yang, PhD, 008613206140093
About this study
The main purpose of this study is to explore if the combination of autologous NK cell infusion and chemotherapy can increase the therapeutic efficiency in the treatment of non-small cell lung cancer compared with chemotherapy alone.
Read the detailed description
Natural killer cells play an important role in the anti-tumor process mediated by innate immunity. However, past researches showed dissatisfactory clinical outcome in clinicaltrials using autologous NK cell infusion alone. With the expectation that the combination of autologous NK cell infusion and chemotherapy may increase the therapeutic efficiency of chemotherapy alone in cancer treatment, the investigators design and conduct this randomized controlled trial in the treatment of non-small cell lung cancer.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- NK cells, Taxol, Carboplatin
- Keywords
- Natural killer cells, NSCLC, NCT, Combined therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK cellsBiological
Also called natural killer cell infusion
Natural killer cell infusion is an intervention between two arms. Dosage of infused cell >1×10^9，q28d*4
TaxolDrug
Also called TAX
135-175mg/m2,q28d*4
CarboplatinDrug
Also called Cis-platinum
AUC=5,q28d*4
| Study group | Role | What they receive |
|---|---|---|
| NK infusion+chemotherapy | Experimental | Treatment includes four cycles. For each cycle: Taxol and carboplatin will be given at the first week. Lymphodepletion will be conducted at the second week. Autologous NK cells will be infused at the third week. Each cycle includes four weeks. Receives: Biological: NK cells; Drug: Taxol; Drug: Carboplatin |
| chemotherapy | Active comparator | Receive the same taxol and carboplatin in experimental arm without NK cell infusion. Receives: Drug: Taxol; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants responding to treatment
Response evaluation of treatment with chest CT scan is assessed by RECIST 1.1
Measured: 4 months
Secondary outcomes (2)
Progress free survival(PFS) time
Measured: 2 years
Overall survival time
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiqi Li, Southwest Hospital, China
- Investigators
- Cheng Qian, MD, PhD, Study chair, Biotherapy Center of Southwest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734524
- Sponsor's protocol ID
- TMMU-BTC-004
- Status last verified
- Jan 2018
- First submitted
- 8 Nov 2015
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Research of NK Cell Infusion Combined With Chemotherapy in the Treatment of Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02734524
- Acronym / sponsor ID
- TMMU-BTC-004
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Natural killer cells, NSCLC, NCT, Combined therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to explore if the combination of autologous NK cell infusion and chemotherapy can increase the therapeutic efficiency in the treatment of non-small cell lung cancer compared with chemotherapy alone.
Detailed description
Natural killer cells play an important role in the anti-tumor process mediated by innate immunity. However, past researches showed dissatisfactory clinical outcome in clinicaltrials using autologous NK cell infusion alone. With the expectation that the combination of autologous NK cell infusion and chemotherapy may increase the therapeutic efficiency of chemotherapy alone in cancer treatment, the investigators design and conduct this randomized controlled trial in the treatment of non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NK infusion+chemotherapy | Experimental | Biological: NK cells, Drug: Taxol, Drug: CarboplatinTreatment includes four cycles. For each cycle: Taxol and carboplatin will be given at the first week. Lymphodepletion will be conducted at the second week. Autologous NK cells will be infused at the third week. Each cycle includes four weeks. |
| chemotherapy | Active comparator | Drug: Taxol, Drug: CarboplatinReceive the same taxol and carboplatin in experimental arm without NK cell infusion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Non-small cell lung cancer must be diagnosed by pathology and staged as ⅢB or Ⅳ with 2009-UICC TNM staging system and operation is excluded due to medical reasons or patient's will.
- According to Response Evaluation Criteria in Solid Tumors(RECIST), at least one measurable or evaluable nidus can be detected by chest CT.
- ECOG score 0-1.
- Gender is not limited, age from 18 years to 75 years.
- Patients are expected to survive for more than 3 months by their physicians at the time of enrollment.
Key exclusion criteria (11 listed)
- Subjects meeting any of the following criteria are not eligible for participation in the study:
- Frequent infection history and recent infection is uncontrolled.
- Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
- Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. For additional details regarding use of steroid and immunosuppressant medications.
- Pregnancy and nursing females.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NK cellsAlso: natural killer cell infusionNatural killer cell infusion is an intervention between two arms. Dosage of infused cell >1×10^9，q28d*4 | Biological | NK infusion+chemotherapy |
| TaxolAlso: TAX135-175mg/m2,q28d*4 | Drug | NK infusion+chemotherapy, chemotherapy |
| CarboplatinAlso: Cis-platinumAUC=5,q28d*4 | Drug | NK infusion+chemotherapy, chemotherapy |
Primary outcome
Number of participants responding to treatment
Time frame: 4 months
Response evaluation of treatment with chest CT scan is assessed by RECIST 1.1
2 secondary outcomes
Progress free survival(PFS) time
Time frame: 2 years
Overall survival time
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng Qian, MD, PhD study chair
Biotherapy Center of Southwest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NK cells, Taxol and Carboplatin in people with Non-small Cell Lung Cancer, run by Southwest Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng Qian, MD, PhD (0086-023-68765461, cqian3184@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants responding to treatment (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.